Sterility Testing Isolators

Fedegari Sterility Testing Isolators – The FCTS Range

The FCTS Sterility Test Isolators have been designed for pharmaceutical samples taken from manufactured drug batches and meet all the requirements of the FDA, EMA, WHO and associated pharmacopoeia as well as all applicable EN standards and directives and international norms.

Product Features

The FCTS Isolators are equipped with the built-in FHPV- Fedegari Hydrogen Peroxide vaporizer, totally engineered and manufactured in-house by Fedegari. With control loop (PID based), the FHPV provides superior reliability and repeatability for easier validation.

  • Fixed concentration profile
  • Gloves and leak testing totally managed by Thema4
  • Significantly reduced operational costs with non-proprietary consumables
  • Cost-effectiveness
  • Purpose-built components
  • Silicon self-retractable gaskets for 100% air tightness

Contact us for more information or call us on +44 (0)1293 824 400

Recent Posts

Preparing for Brexit

We pride ourselves on supporting our customers especially through this turbulent time. We are developing a plan to limit the impact of Brexit so you can be assured our support will not be affected. 

SPARE PARTS STOCKPILING

We are Stockpiling service kits in Ireland for all our SLA customers and increasing our critical spares held within Ireland, criticality based around usage levels and risks.

DELIVERIES

We are allowing for some delays due to border entry points within our planning & logistics control.

SITEWORK

As we aim to service equipment predominantly from our Irish team of Operations Engineers, Brexit should not interrupt service levels. Our principal suppliers are from Italy in the EU so any additional support labour is also not a concern.

INVOICING & PAYMENTS

All our Irish customers payments will be processed via our Euro bank account so will not be affected by exchange rate risks.